After hearing testimony that the drug increases the risk of suicidal thoughts, even in patients without a history of depression, Federal health officials unanimously rejected the weight loss drug, rimonabant, manufactured by Sanofi-Aventis SA. The panel said that the company failed to show the drug is safe.
Judging from the back-to-back 14-0 votes by the expert panel it is unlikely the Food and Drug Administration will approve the drug. The agency usually follows its panel’s advice, but it isn’t required to do so.
“There is a reasonable suspicion we better learn some more and watch this affair more closely before we launch into massive use of this drug,” said panelist Dr. Jules Hirsch, a senior physician at New York’s Rockefeller University.
Patients who were given the once-daily tablet in tests reported twice as many psychiatric side effects, including depression, anxiety and sleep problems, than those who received a placebo, Dr. Amy Egan, an FDA medical officer, told the advisers.
Officials from Sanofi-Aventis suggested that patients be screened for depression before they are prescribed the drug. They also advised that patients visit their doctors five times during the first year of treatment for reassessment to further curtail any potential problems.
“Who is the right patient to receive rimonabant? Not everybody,” Sanofi-Aventis’ Richard Gural said. The drug is not appropriate for anyone with a history of depression or suicidal thoughts, or who is taking antidepressant medication, he added.
The FDA will make a final decision on the drug by July 27,2007.
The company proposes selling the drug under the brand name Zimulti. Rimonabant already is sold in Europe as Acomplia.
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